38 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814794·GENUMEDI EXTRA WIDE SILVER SIZE VI
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04049772814749·GENUMEDI EXTRA WIDE SAND SIZE VI
FlexStep
FDA UDI
Liftup A/S·05714420031166·FlexStep V2, 900, 3+1 step, indoor
PMT CORPORATION - STEREOTACTIC
FDA UDI
PMT CORPORATION·00650551038849·ROD
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837027155·PLATEAU Interbody, Curved, Bulleted, 11mm 31mm ...
DURQ/ QUALIDURA
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASERTOUCHONE (OTC)
FDA 510(k)
FDA Class 2
·Neurology
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·January 12, 2021
T:SLIM G5 SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code OYC·December 1, 2017
GALAXY G3 MINI 1MM X 2CM
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code KRD·December 5, 2020
NC TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Injury
·ABBOTT VASCULAR·Product code LOX·December 16, 2022
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 20, 2016
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·May 27, 2025
FLANGE FIXTURE AND ABUTMENT
FDA Adverse Event
Injury
·COCHLEAR BONE ANCHORED SOLUTIONS AB·Product code LXB·May 9, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·September 19, 2014
PROCEED VENTRAL PATCH
FDA Adverse Event
Injury
·ETHICON·Product code FTL·May 25, 2011
TREK¿
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR INC.·Product code LOX·January 7, 2026
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code LWS·April 10, 2013
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·April 10, 2013